Contrast-Enhanced Ultrasound Evaluation of Bowel Wall Inflammation in Pediatric Crohn's Disease: Comparison to CT and MRI Enterography
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Degree of bowel wall enhancement
研究概览
简要总结
The investigators plan to compare contrast-enhanced ultrasound to CT and MRI for the detection and quantification of intestinal inflammation in the the setting of pediatric small bowel Crohns disease
详细描述
The proposed study will investigate the use of an FDA-approved ultrasound microbubble contrast agent (Lumason; Bracco Diagnostics) in pediatric and adult Crohn's disease patients undergoing either MR enterography (MRE, or MRI of the bowel) or CT enterography (CTE, or CT of the bowel). In April 2016, Lumason was FDA approved for intravenous administration and imaging of the liver in children. Imaging of the bowel will employ an identical administration method to that described for liver imaging, but the ultrasound transducer will be placed over the affected intestines as opposed to liver.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologic evidence of small bowel Crohn's disease, or clinical evidence of disease (including radiologic confirmation [either CT or MRI] and receiving medical therapy for Crohn's disease).
- •Between ages 10 and 18 years.
- •Undergoing clinically-indicated CTE or MRE with evidence of active disease based on pediatric gastroenterologist clinical assessment
排除标准
- •Patients under the age of 10 or over the age of
- •Pregnancy or breast feeding. Urine pregnancy testing will be performed on all female study participants of reproductive potential.
- •Obesity/body habitus preventing visualization of small bowel affected by Crohn's disease by ultrasound (Body mass index ≥30 kg/m2
- •Subject inability/unwillingness to consent or child assent, including severe developmental delay/mental retardation.
- •Prior allergic-like reaction or other severe adverse event to Lumason or any of the active ingredients in Lumason (SPECIFIC CONTRAINDICATION from Package Insert).
- •Known unstable cardiopulmonary conditions (including any history of acute myocardial infarction/acute coronary artery syndrome, arrhythmia, and congestive heart failure), ongoing acute or chronic kidney disease (eGFR <30 ml/min), moderate/severe chronic lung disease, and end-stage liver disease.
研究组 & 干预措施
Ultrasound Microbubble Contrast Agent
All subjects will receive intravenous Lumason microbubble contrast agent; there is no comparative ultrasound contrast agent. Contrast Enhanced Ultrasound findings/results will be correlated with comparable, clinically performed, CTE/MRE findings/results
干预措施: Ultrasound Microbubble Contrast Agent (Drug)
Ultrasound Microbubble Contrast Agent
All subjects will receive intravenous Lumason microbubble contrast agent; there is no comparative ultrasound contrast agent. Contrast Enhanced Ultrasound findings/results will be correlated with comparable, clinically performed, CTE/MRE findings/results
干预措施: Ultrasound Imaging (Device)
结局指标
主要结局
Degree of bowel wall enhancement
时间窗: 2 years
Percent hyperenhancement (compared to normal bowel loops)
次要结局
- Overall Disease Status for imaged section(2 years)
- Degree of mesenteric inflammation(2 years)
- Maximum Bowel Wall Thickness(2 years)